Five models for regulating drug supply

Five models for regulating drug supply
Five models for regulating drug supply2018-11-29T14:00:27+01:00

Regulated drug markets in practice

There are five basic models for regulating drug supply. We describe them below, starting with the most restrictive and moving to the most open. Variants on these models already exist and function across the world, supporting the entirely legal distribution of a range of medical, quasi-medical and non-medical psychoactive drugs.

Of course, the precise nature of the respective regulatory frameworks and enforcement infrastructure varies from country to country.

There is also some degree of boundary blurring between these models. This leads to a certain amount of generalisation, but also helps emphasise that such models will inevitably operate differently in different locations.

We have also made some basic suggestions as to how to adapt these basic models to cater for the challenges of non-medical drug supply in the future.

Prescription.

  • The prescription model is the most tightly controlled and enforced drug supply model currently in operation. Under this model, drugs are prescribed to a named user by a qualified and licensed medical practitioner. They are dispensed by a licensed practitioner or pharmacist from a licensed pharmacy or other designated outlet.
  • The process is controlled by a range of legislation, regulatory structures and enforcement bodies. These guide, oversee and police the prescribing doctors and dispensing pharmacists. They also help determine which drugs are available, in what form, where, and under what criteria.
  • As the most tightly controlled and enforced supply model, the prescription model is the most expensive to administer. It is limited to medical necessity, which restricts its actual or potential use to the problematic/chronic dependent end of the drug use spectrum. Most commonly, it supports maintenance prescribing as part of a treatment regimen or harm reduction programme. As such it will only ever involve a small fraction of the total drug using population, although it should be noted that this user group is disproportionately associated with the greatest personal and societal harms (especially under prohibition).
  • Substitute opiates such as methadone are the most commonly prescribed under such scenarios. Prescribed injectable heroin (diamorphine) also has a long history, and established evidence base. Less common, although not unknown, is the prescription of stimulants, including amphetamines and cocaine.
  • These long established models serve as an island of regulation for the very same drugs that are prohibited in all other scenarios. They provide a useful, if limited, demonstration of how legal regulation of drugs can help people become prescribed, rather than street, users; a clear example of the benefits of decriminalisation of drug use and regularisation of their supply route.
  • This is particularly important given that such legal models have only evolved within generally hostile prohibition environments. As a rule, they have been minimally funded and politically unpopular. It is hard to know how such services would develop if managed with the latitude afforded to other, less controversial areas of patient care such as, for example, diabetes or mental health.
  • Additional tiers of regulation have often been introduced within the basic prescribing model. These include requirements for consumption to be supervised in a specific venue, for very specific qualifying criteria to be met, or for the prescribing doctor to obtain a special licence. Prescribing is often time limited, administered in progressively reduced dosage, or made conditional on the patient meeting specific rehabilitation milestones.
  • Some prescribing occurs in a grey area, where medical necessity has evolved into what is effectively maintained dependence. This is far more widespread, and includes dependence on various painkillers (e.g. Vicodin, OxyContin) and tranquillisers (e.g. Valium).
  • Maintenance prescribing for dependent users continues to create controversy within the field of medical ethics and practice. It raises some difficult questions for practitioners, as it exposes the grey areas between medical, quasi-medical and non-medical use. There are ongoing controversies and conflicts between the clear need to reduce harms associated with problematic illicit drug use and a reluctance to dispense drugs that are being used in any way non-medically.
  • There are clear benefits of providing a safe and affordable supply of both drug and related paraphernalia. From a medical point of view, these are particularly helpful to those injecting, who are at high risk of contracting blood borne diseases. These benefits are sometimes undermined if practitioners are accused of supporting drug use for pleasure or recreation, while simultaneously ‘failing to treat’—or even ‘endorsing’—dependence.
  • There appears to be a need for this field of care to evolve pragmatically to deal with modern challenges. Specialist training, a specific qualification/licence, or a new specialist prescribing-practitioner professional niche could be put in place. These would be supported by a strictly ethical code of conduct, and clearly defined general guidance. They would potentially be overseen by a new regulatory agency, or equivalent sub-group.
  • Beyond this admittedly European perspective is an extensive, although poorly documented, history of opium registration systems in many Eastern and Middle Eastern countries. Users were registered and managed in Iran until 1953, and then again in the early 1970s (similar programmes are now being cautiously re-introduced); comparable systems also existed in Pakistan and India—where remnants still function—and in Bangladesh, Indonesia, Thailand and elsewhere.

Pharmacy Model.

  • The pharmacy model, whilst still working within a clearly defined medical framework, is less restrictive and controlling than the prescription model. Pharmacists are trained and licensed to dispense prescriptions, although they cannot write them. They can also sell certain generally lower risk medical drugs from behind the counter. Such dispensing generally takes place from licensed pharmacy venues.
  • Pharmacists are overseen by regulatory legislation, managed by various agencies and a clearly defined enforcement infrastructure. They either fulfil prescriptions, or sell over the counter products. Access to the latter is only possible if firm, non-negotiable criteria are met. These include restrictions according to buyer age, level of intoxication, quantity requested, or case-specific concerns relating to potential misuse. In addition, pharmacists are trained to offer basic medical advice, support and information.
  • In some places, pharmacists are already involved in drug management regimes. For example, in the UK, they are required to supervise the on-site consumption of some maintenance methadone prescriptions—a precaution against diversion to the illicit market.
  • The existing pharmacy model is not directly involved in dispensing or vending drugs for non-medical use. However, it could easily be adapted and developed into an effective way of managing the availability of currently illicit drugs for such purposes. Licensed and trained professionals could serve as gatekeepers for a range of such drugs. They would be legally required to restrict sales according to the kind of strict criteria defined above, and would also act as a source of realistic, well informed and practical advice and support.
  • A specialist, non-medical drug pharmacist would occupy a distinct professional niche, one that would need careful development, definition and management. This new role would be subject to a similar code of practice to that of more conventional pharmacists, but with additional access control criteria. These specialist pharmacists would also be required to offer advice about harm reduction, safer use, and treatment services and referrals to help users quit, where appropriate. Such advice would be supported by necessary additional training or experience in drug counselling. They could either operate alongside existing pharmacies (subject to appropriate licensing conditions) or from separate licensed outlets.

Licensed Sales.

  • Current best practice in licensed sales of alcohol and tobacco offers a less restrictive, more flexible infrastructure for the licensed sales of certain lower risk non-medical drugs. Such a system would put various combinations of regulatory controls in place to manage the vendor, the supply outlet, the product and the purchaser, as appropriate.
  • Much like current best practice in alcohol and tobacco management programmes, a raft of centrally determined framework policy and regulatory legislation would be put in place. This would be overseen and enforced by municipal, regional or national authorities, according to local legal and cultural norms. These authorities would act as the licensing body, and would be able to tailor the regulatory framework to local needs and policy priorities. They would be supported by police, customs, trading standards, and health and safety infrastructure, as appropriate.
  • As noted in the pharmacy model above, licence holders could be required to offer advice about harm reduction, safer use, and treatment services, where appropriate. They might also be required to undergo necessary additional training in drug counselling, or to have pre-existing drug counselling experience.

Licensed Premises.

  • Public houses and bars serving alcohol offer the most common example of premises licensed for sale and consumption. Under this long established system, various controls exist over the venue and (in particular) the licensee. He or she is responsible for restricting sales on the basis of age, intoxication and hours of opening.
  • The licensing authority is usually a tier of local government, which manages and enforces a series of centrally determined regulations. A clearly defined hierarchy of sanctions for licence infringements includes a sliding scale of fines, loss of licence, and even criminal penalties. Licensees can also be held partially or wholly liable for how their customers behave—punishable examples include anti-social behaviour, noise, littering and drink driving.
  • The cannabis ‘coffee shop’ system in the Netherlands offers another useful example of premises licensed to sell more contentious products. Through these coffee shops, the Dutch authorities have gone some way towards legally licensing the sale and consumption of cannabis. However, it should be noted that, even here, the cannabis trade is not subject to full legal regulation; supply to the coffee shops remains illicit, even though low level supply and consumption within them is tolerated. The coffee shops themselves operate under a range of strict—and strictly policed—conditions.
  • Supervised venues for the dispensing and consumption of prescribed diamorphine (heroin) are another form of licensed venue. They are subject to strict licensing, regular external scrutiny and firm enforcement, although they only provide drugs on a prescription basis.
  • Lessons can also be learned from licensing and regulating regimes put in place to manage other restricted (and potentially harmful) activities including gambling, certain kinds of entertainment, and sex work.
  • The examples given above suggest that a functioning licensed premises for drugs would remain relatively restricted in terms of how it offered drugs, and who it offered them to. Given this, it could combine elements of existing licensed premises, licensed sales, and specialist pharmacy models, to ensure that moderate drug use took place in a safer, more supportive environment.

Unlicensed Sales.

  • Certain psychoactive substances deemed sufficiently low risk, such as coffee, traditional use of coca tea and some low strength painkillers, are subject to little or no licensing. Here, regulation focuses on standard product descriptions and labelling. Where appropriate, food and beverage legislation (dealing with packaging, sell by dates, ingredients etc.) comes into play. These substances are effectively freely available, although they may in some cases be subject to certain localised restrictions or voluntary codes.

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